FDA 483 - Hainan Shuangcheng Pharmaceuticals Co Ltd - April 24, 2019

An FDA inspection of Hainan Shuangcheng Pharmaceuticals Co., Ltd. in Haikou City, China, revealed significant deficiencies. Observations included inadequate controls over computer systems for user privileges, insufficient environmental monitoring in aseptic processing areas, and a lack of proper training for personnel performing visual inspections. Additionally, procedures to prevent microbiological contamination of sterile drug products were not adequately established or followed.